Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?
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|ClinicalTrials.gov Identifier: NCT00306475|
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : January 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: divalproex sodium ER Drug: placebo||Phase 4|
Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.
The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
|Active Comparator: 1||
Drug: divalproex sodium ER
divalproex sodium ER1000 mg
|Placebo Comparator: 2||
placebo identical in appearance to active comparator
- Improvements in cognition and psychopathology [ Time Frame: six weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306475
|United States, Tennessee|
|Psychiatric Hospital at Vanderbilt|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Stefania Bonaccorso, M.D.||Vanderbilt University Medical Center|